Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 2:47 PM
Study NCT ID:
NCT04254133
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-22
First Post:
2020-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GIFTS
Brief Summary:
This trial studies the role of inherited (present at birth) mutations in cancer risk genes such as BRCA2, BRCA1, ATM, CHEK2, and others in relation to prostate cancer. This study may help researchers understand the frequency and importance of inherited mutations in cancer risk genes in patients with prostate cancer and potentially help identify better ways to treat cancer in patients who have a mutation in one of these genes.
Detailed Description:
OUTLINE:
Participants complete questionnaire over 20 minutes at baseline, then undergo collection of saliva sample for genetic testing. Participants identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene undergo genetic counseling. Participants whose genetic testing does not indicate an inherited mutation in a DNA repair gene receive a letter thanking them for their participation and emphasizing the importance of ongoing communication with their physician and family members about cancer risk.
Participants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.
Participants complete questionnaire over 20 minutes at baseline, then undergo collection of saliva sample for genetic testing. Participants identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene undergo genetic counseling. Participants whose genetic testing does not indicate an inherited mutation in a DNA repair gene receive a letter thanking them for their participation and emphasizing the importance of ongoing communication with their physician and family members about cancer risk.
Participants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P50CA097186 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2020-00933 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 8754 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View |